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临床试验/NCT03635697
NCT03635697终止不适用

The Effect of an Auditory Mindfulness Intervention During NST Appointments on Depression and Anxiety in Pregnant Women

UConn Health1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
15
试验地点
1
主要终点
Beck Anxiety Inventory Score

研究概览

简要总结

This study aims to determine if a short audio clip about mindfulness implemented during NST appointments can lower pregnant women's levels of anxiety and depression. Subjects will be placed into either the intervention group or a control group. The intervention group will be asked to listen to a short audio clip on mindfulness during their NST appointments, and the control group will receive the standard of care during NST appointments. Subjects will be asked to take two surveys about anxiety and depression three times throughout the study: before the intervention, after the intervention, and 6 weeks postpartum.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •18 years or older
  • •English as primary language
  • •less than 36 weeks gestational age
  • •at least 28 weeks gestational age

排除标准

  • •Use of psychoactive medications
  • •Any psychiatric diagnosis with dissociative, hallucinatory, and/or delusional features
  • •History of suicide attempt or current suicidal ideations
  • •Uncontrolled substance abuse in the last 6 months
  • •Patients with hearing loss
  • •More than three no-shows to NST appointments

研究组 & 干预措施

Mindfulness Intervention Group

Experimental

Participants in this group will listen to a short mindfulness audio clip during 6 of their NST appointments.

干预措施: Mindfulness Auditory Intervention (Behavioral)

Control Group

No Intervention

Participants in this group will have the regular standard of care for their NST appointments.

结局指标

主要结局

Beck Anxiety Inventory Score

时间窗: Over the course of 6 intervention sessions, followed by 6 weeks postpartum

We are looking for the members of our intervention group to see a change in their scores on the Beck Anxiety Inventory after completing 6 sessions of listening to a mindfulness clip. We expect to see this score change after the full-course of the intervention is complete. We also hope to see this change in score persist at the 6-week postpartum visit. This scale aims to measure anxiety symptoms, and total scores range from 0-36. Lower scores indicate lower levels of anxiety symptoms, and thus a better outcome.

Edinburgh Postnatal Depression Scale Score

时间窗: Over the course of 6 intervention sessions, followed by 6 weeks postpartum

We are looking for the members of our intervention group to see a change in their scores on the Edinburgh Postnatal Depression Scale after completing 6 sessions of listening to a mindfulness clip. We expect to see this score change after the intervention is complete. We also hope to see this change in score persist at the 6-week postpartum visit. This scale aims to measure depressive symptoms, and total scores range from 0-30. Lower scores indicate lower levels of depressive symptoms, and thus a better outcome.

次要结局

未报告次要终点

研究者

发起方
UConn Health
申办方类型
Other
责任方
Sponsor

研究点 (1)

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